CIED Lead Management: Does the Past Predict the Future?

Case Presentation

A 69-year-old male with established non-ischemic cardiomyopathy and end-stage renal disease (ESRD) was admitted to our teaching hospital with complaints of weakness. He had a long-established history of end-stage renal disease, and over the past 12 months, had a host of complicating factors limiting the effectiveness of dialysis. The diagnosis of hyperkalemia was noted in the emergency department, and serum potassium at the time of admission was 7.1.

In the preceding year and prior to this presentation to the ED, a previously placed left upper extremity AV fistula failed due to complications with maturation. At that time, a left-sided tunneled catheter was placed. Due to poor flow issues, this was also rate limiting in hemodialysis, and over the course of the ensuing weeks, slowly began to fail.

In 2012, prior to vascular access attempts for left upper extremity dialysis access, a right-sided single-chamber ICD utilizing a dual-coil right ventricular high-voltage lead was implanted by an outside operator for primary prevention of sudden cardiac death. 

Given these issues and presentation of hyperkalemia, urgent hemodialysis was required. Two-view chest x-ray (PA/lateral) was obtained (Figure 1). Right-sided axillary venous access was unsuccessfully attempted due to inability to move the guidewire past the right innominate-SVC junction. Venograms illustrate the tandem occlusions in the right axillary vein along with complete SVC occlusion (Figures 2-4). 

Due to the continued urgent need for dialysis, vascular access was obtained in the right femoral vein, and the patient was successfully dialyzed using a standard hemodialysis catheter with a transfemoral approach. Given the above issues and lack of central venous access available for long-term dialysis use, our interventional and vascular access colleagues were asked to re-establish access via venoplasty. Using a left femoral venous approach, flush occlusion in the SVC was seen. This was unable to be negotiated, and attempts at crossing were unsuccessful. Further attempts at crossing the bilateral upper extremity occlusions were also unsuccessful. Our patient continued to receive inpatient hemodialysis via the right femoral vein catheter. Unfortunately, due to previous complications from bladder adenocarcinoma, a radical cystectomy was performed and an ileal conduit was placed surgically. Because of this, our patient was felt to be at high risk of developing peritonitis; although ambulatory peritoneal dialysis was considered, it was not offered.

During an interdisciplinary consultation with our vascular and interventional colleagues, we were asked to assist. The discussion centered largely around attempts at re-establishing vascular access via crossing the upper extremity occlusion and venoplasty. After reviewing the venography, we felt that the anatomy was unfavorable and that prior attempts predicted a low likelihood of success.

Fortunately, in reviewing the patient’s device diagnostics, the right ventricular pacing burden was less than 1%. He had never received any high-voltage therapy for ventricular arrhythmias or antitachycardia pacing. Given the lack of pacing indication and need to re-establish vascular access, we offered complete system extraction of the right ventricular ICD lead. By sacrificing the ICD lead, the access provided could allow replacement of the ICD lead with a new hemodialysis catheter. 

The ejection fraction had remained low through the years following implant, ranging from 25-30%. Given the ongoing Class I indication for the ICD, we felt we could mitigate the risk of sudden death with implantation of a subcutaneous ICD after removal of the transvenous system. After appropriate ECG screening, our patient was deemed a candidate for the subcutaneous ICD.

After obtaining informed consent, the patient was prepped and draped in the usual fashion. Bilateral femoral venous and arterial access was obtained in case an open rescue was needed. A Bridge Occlusion Balloon (Spectranetics) was not placed given SVC occlusion. A transesophageal echo probe was placed for assisting with hemodynamic monitoring during the procedure. Next, the ICD pulse generator pocket was opened, and access to the dual-coil single-chamber ICD lead was established. The lead was cut, and an LLD EZ lead locking device (Spectranetics) was advanced to the tip of the lead and deployed. The high-voltage cables were tied off, as is our usual practice. Next, using a 13 French TightRail Rotating Dilator Sheath (Spectranetics), the lead was engaged. Heavy calcification was encountered at the venotomy site; however, we were successful in advancing the extraction sheath past this area and ultimately along the lead into the RV apex, and lead was removed easily. Next, the TightRail sheath was withdrawn slightly to the lower right atrium, and an Amplatz .035 Extra-Stiff Wire (Cook Medical) was advanced into the inferior vena cava. 

Next, after excluding significant effusion by TEE, using the Amplatz Extra-Stiff Wire, a tunneled hemodialysis catheter was placed through the skin surrounding the ICD pulse generator pocket and into the right atrium. The catheter was flushed, loaded with heparin solution, and then capped, as per our nephrology associates’ standard practice. Prior to capping, the catheter was flushed aggressively, and good flow through both lumen was verified.

We then turned our attention to placement of the subcutaneous ICD. After marking appropriate landmarks using fluoroscopy, the subcutaneous ICD was placed uneventfully along the left-sided axilla and chest. Defibrillator threshold testing was performed, and the device successfully terminated ventricular fibrillation with a single shock. 

The next day, our patient underwent hemodialysis using the newly placed right upper extremity tunneled catheter. He was discharged later that day, after the previously placed right femoral venous dialysis sheath was removed. 

Discussion

This case and manner of presentation highlight the many complexities seen in patients with end-stage renal disease, and more specifically, those requiring scheduled hemodialysis. First and foremost, we describe a “rescue” that can be offered to patients in this situation, as this is not a unique presentation. We frequently encounter access issues in patients requiring device upgrades in the setting of concomitant ESRD.^1-4 Reviewing the available information at the time of index implant in 2012, a Class I indication was present for primary prevention of sudden cardiac death; however, no identifiable pacing needs were identified. Given the availability of the subcutaneous ICD at the time of initial implant, the above-described situation could have been avoided. 

The combination of cardiomyopathy and reduced ejection fraction, along with advanced chronic kidney disease, is frequently seen in our patient population. When discussing with these patients the risk of sudden cardiac death and their options for mitigating this risk via a traditional ICD implant for primary prevention, it is our opinion that the risk of vascular issues going forward should be included in the discussion. Furthermore, it is imperative that the astute implanting physician review the actual risk of sudden death based on the type of cardiomyopathy as well as potential need for pacing going forward. We feel strongly that if no pacing indication is identified, then a non-transvenous ICD system, specifically the subcutaneous ICD, should be offered to these high-risk patients. 

As life expectancy and the number of younger individuals receiving a CIED increases, the device-years per person will also increase, along with the accompanying potential risks of infection, lead malfunction, and the need for system upgrade. This augments the likelihood of the eventual need for implantation via the contralateral venous system. In trained operators, extraction of leads in a variety of settings has a well-established safety profile.^5-7 Physicians performing CIED implants are required to evaluate and implement the best lead management strategy for each individual, not only for the immediate procedure, but also for future procedures. It is imperative to preserve venous access and not venous patency — in our opinion, preservation of venous access is essential for responsible lead management. 

Within 4 to 5 days of implant, near-complete encapsulation of intravascular pacing leads with a fibrin sheath has been observed in addition to extensive thrombosis.^8-9  Younger patients develop more vigorous fibrotic responses and more frequently develop progressive calcification.⁷ Several clinical studies have similarly demonstrated the common occurrence of venous stenoses and occlusion after endovascular pacing and defibrillator lead placement; however, the venous pathology is frequently asymptomatic.⁸ In contrast, little is known about the effects of lead extraction on venous patency, and attempts to study this have been confounded by ipsilateral re-implantation, making it impossible to isolate the effects of extraction.⁹

As implanters, it is important that vascular access not be taken for granted. After a full discussion and disclosure regarding the merits of traditional transvenous system is undertaken, an educated and informed patient decision can be made, potentially avoiding clinical situations as described here. Given the growing frequency of this type of access issue, along with the significantly elevated risk of gram-positive bacteremia and lead-related endocarditis in dialysis patients,^10-12 we as implanters feel strongly that subcutaneous ICD and leadless device technology be considered more broadly in this high-risk patient population.

Disclosures: The authors have no conflicts of interest to report regarding the content herein.   

References

1. Voigt A, Shalaby A, Saba S. Continued rise in rates of cardiovascular implantable electronic device infections in the United States: temporal trends and causative insights. Pacing Clin Electrophysiol. 2010;33:414-419. 
2. Cabell CH, Heidenreich PA, Chu VH, Moore CM, Stryjewski ME, Corey GR, Fowler VG Jr. Increasing rates of cardiac device infections among Medicare beneficiaries: 1990–1999. Am Heart J. 2004;147:582-586. 
3. Pakarinen S, Oikarinen L, Toivonen L. Short-term implantation-related complications of cardiac rhythm management device therapy: a retrospective single-centre 1-year survey. Europace. 2010;12:103-108. 
4. Wilkoff BL, Love CJ, Byrd CL, et al. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: this document was endorsed by the American Heart Association (AHA). Heart Rhythm. 2009;6:1085-1104. 
5. Wazni O, Epstein LM, Carrillo RG, et al. Lead extraction in the contemporary setting: the LExICon Study: an observational retrospective study of consecutive laser lead extractions. J Am Coll Cardiol. 2010;55:579-586. 
6. Wilkoff BL, Byrd CL, Love CJ, et al. Pacemaker lead extraction with the laser sheath: results of the pacing lead extraction with the excimer sheath (PLEXES) trial. J Am Coll Cardiol. 1999;33:1671-1676. 
7. Byrd CL, Wilkoff BL, Love CJ, et al. Intravascular extraction of problematic or infected permanent pacemaker leads: 1994-1996. U.S. Extraction Database, MED Institute. Pacing Clin Electrophysiol. 1999;22:1348-1357. 
8. Gula LJ, Ames A, Woodburn A, et al. Central venous occlusion is not an obstacle to device upgrade with the assistance of laser extraction. Pacing Clin Electrophysiol. 2005;28:661-666. 
9. Le Franc P, Klug D, Jarwe M, et al. Extraction and reimplantation of defibrillation leads through a thrombotic subclavian vein. Pacing Clin Electrophysiol. 1999;22:977-978. 
10. Matthews DM, Forfar JC. Superior vena caval stenosis: a complication of transvenous endocardial pacing. Thorax. 1979;34:412-413. 
11. Mazzetti H, Dussaut A, Tentori C, Dussaut E, Lazzari JO. Superior vena cava occlusion and/or syndrome related to pacemaker leads. Am Heart J. 1993;125:831-837. 
12. van Rooden CJ, Molhoek SG, Rosendaal FR, Schalij MJ, Meinders AE, Huisman MV. Incidence and risk factors of early venous thrombosis associated with permanent pacemaker leads. J Cardiovasc Electrophysiol. 2004;15:1258-1262.